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Expert Financial Analysis and Reporting

Post archive for ‘Company Reports’

Bristol-Myers Squibb: Why I Believe Its Dominance in Cancer Immunotherapy Promises to Make BMY a Great Long-Term Investment (BMY, $62.70, Buy)

Investment Opinion Conceptual Reason for Recommendation My recommendation of Bristol-Myers Squibb is in contrast to the small, not well-researched biotechnology companies on which I usually focus. BMY is a large, complex and well analyzed multinational company with a broad product portfolio and burgeoning pipeline. It requires as much time to analyze as several small biotechnology […]

Antares Pharma: Update on Xyosted (ATRS, Buy, $2.34)

Regulatory Update Antares announced that it has scheduled a Type A meeting with FDA for Xyosted which is intended to resolve issues that have stalled the FDA regulatory review. Antares requested the meeting on December 21, 2017 in response to a Complete Response Letter on Xyosted. The meeting will take place on February 21, 2018. […]

Northwest Biotherapeutics: Two Lead Investigators on DCVax-L Phase 3 Trial Believe That It Could be a Major Therapeutic Advance in Treating Glioblastoma Multiforme (NWBO, Buy, $0.29)

Reason for this Note I was prompted to write this note after listening to a July 2017, You Tube segment in which Dr. Keyoumers Ashkan spoke about his belief that DCVax-L could be a major advance in the treatment of brain tumors. Here is the link to this approximately 13 minute video. His comments on DCVax-L […]

Northwest Biotherapeutics: Issues to Focus on in Pending Manuscript Dealing with Blinded Data from Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma (NWBO, Buy, $0.23)

Purpose and Summary of This Report My key takeaway points are summarized at the end of this report. I urge you to first go through the full text, but if for whatever reason you are impatient, you can start from the back of the report. The primary purpose of this report is to provide data […]

Portola Announces a Delay in PDUFA Date for AndexXa (PTLA, Buy, $54.86)

Portola announced after the close on December 22, 2017 that the FDA will extend its review of AndexXa (andexanet alfa) by 90 days. According to the Company, it just submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process.  This constitutes an amendment to the submission […]

Antares’ Response to Complete Response Letter on Xyosted is in Line with My Expectations (ATRS, Buy, $2.05)

Antares Pharma announced on December 21st that it had submitted a request to the FDA for a type A meeting in response to the CRL that it received in October on Xyosted. This action and timing is in line with what I have been expecting. See my note of November 9, 2017:  My Hypothesis on […]

Portola: US Launch of Bevyexxa Is Scheduled for Early January 2018 (PTLA, Buy, $50.03)

Portola Pharmaceuticals announced today that the FDA has given the go-ahead for the commercial launch of Bevyxxa (betrixaban). This drug was approved in the US on June 23, 2017 and at the time Portola said that it expected to launch Bevyexxa in the US in the September to November time frame. However, in early September […]

Cytokinetics: VITALITY-ALS Trial Fails (CYTK, Buy, $8.00)

CYTK announced today that the VITALITY-ALS trial in ALS failed which is obviously a significant disappointment. The stock is trading down to $8.00 in pre-market trading. I had thought that there was a good chance for success in the trial, but recognized that ALS is a tough disease in which there have been innumerable drug […]

Alimera : Changing from A Buy to Hold (ALIM, $1.20, Hold)

After four years of following Alimera and never having a Buy on the Company, I upgraded to a Buy in a report published on June 21, 2017: Iluvien Sales Seem to Have Caught Traction; It Is Time to Buy! (ALIM, Buy, $1.35). The basis for my upgrade was two-fold. Very importantly US unit growth for Iluvien […]

Antares Pharma: My Hypothesis on Issues that Resulted in the CRL for Xyosted and Potential Timing of Approval (ATRS. Buy, $1.63)

Investment Thesis Xyosted is viewed by investors as the most important product in Antares” broad pipeline. In anticipation of approval on the PDUFA date of October 20, 2017 the stock price reached a high of $3.96 on October 10. Unexpectedly, Antares announced on October 11 that the FDA had identified deficiencies that prevented going forward […]